At a glance

ClinicalIndex Comparison Record

Phase 3Terminated· 220 enrolled

Drug / intervention

Dexamethasone +3 moredrug

Likely dose

Dexamethasone 0.15 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00005777

NCT00005777Phase 3Terminated

Terminated

Compare CT.gov

Randomized Trial of Minimal Ventilator Support and Early Corticosteroid Therapy to Increase Survival Without Chronic Lung Disease in Extremely-Low-Birth-Weight Infants

NICHD Neonatal Research Network·interventional·Posted Jun 2, 2000·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Minimal mechanical ventilation management, Routine mechanical ventilation management, and 2 other interventions for Bronchopulmonary Dysplasia and 5 related conditions. Terminated early, enrolled 220 participants across 13 sites.

Signals

Trial was terminated early

Detailed Summary

This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBronchopulmonary Dysplasia, Respiratory Distress Syndrome, Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 3TerminatedFinished

199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 1998

Primary CompletionSep 1998

First PostedJun 2000

Study CompletionSep 2002

TodayJul 2026

First PostedJun 2, 2000

Enrollment StartFeb 1, 1998

Primary CompletionSep 1, 1998

Study CompletionSep 1, 2002

TodayJul 1, 2026

Enrollment to primary: 7 monthsPosted 26.1 years ago

Interventions

Minimal mechanical ventilation managementprocedure

Partial pressure of carbon dioxide (PCO2) target (\>52 mm Hg)

Routine mechanical ventilation managementprocedure

Partial pressure of carbon dioxide (PCO2) target \<48 mm Hg)

Dexamethasonedrug

Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place.

Placebodrug

The infants in the placebo groups received equal volumes of saline.